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PCI Biotech full year 2024 interim results

Oslo (Norway), 27 February 2025 – PCI Biotech (OSE: PCIB), today announces its preliminary full year 2024 results. Please find enclosed the interim report and presentation.

Highlights review

Operations
PCI Biotech’s 2024 development goals were to demonstrate scalability and manufacturing process benefits of the photochemical-based technology (PCL) in viral vector (AAV) manufacturing by advancing the technology into mini benchtop bioreactors, which are considered representative for commercial manufacturing.

Recent mini benchtop bioreactor results indicate that PCL has the potential to release increased levels of viral vectors in the upstream AAV manufacturing process, accompanied by reduced impurity levels. This is an important milestone for PCL and we consider PCL’s scalability as demonstrated by the encouraging upstream results.

These results are in sum expected to translate into increased net manufacturing yield after downstream processing, a highly sought-after feature by the industry. However, more runs in mini benchtop bioreactors with a robust downstream process are needed to prove PCL’s ability to increase net AAV yield in an end-to-end process.

New mini benchtop bioreactor runs to reproduce the recent positive upstream results and demonstrate downstream process benefits are in preparation. Successful results may pave the way for external late-stage field testing in 2H 2025 and potentially make the technology ready for the research market. A 2-year development plan to mark PCL’s readiness for the larger commercial market is in planning.

Corporate
The cash position of NOK 27.1 million per end of December 2024 is estimated to support operations into Q4 2025 with current plans, providing an opportunity window to demonstrate the commercial potential of the technology platform. The company will continue to explore financing and strategic opportunities to secure continued operations.

Ronny Skuggedal, CEO of PCI Biotech, comments: “After receiving encouraging early-stage field testing feedback at the beginning of 2024, we accelerated development by scale-up to mini benchtop bioreactor. Now with encouraging upstream results from two test runs, we consider PCL’s scalability demonstrated also in bioreactor. Feedback from partnering activities underscores the importance of being able to translate these upstream results into increased net manufacturing yield after downstream processing. New test runs for demonstrating PCL’s end-to-end manufacturing benefits are in planning, and we are eager to continue working at this commercially representative scale. We have in parallel started to look at a potential development leap directly into commercial systems, made possible by an off-the-shelf 50L bioreactor with built-in LEDs suitable for PCL. A successful demonstration in 50L bioreactor would mark PCL’s readiness to address the capacity challenges in the commercial viral vector manufacturing market.”

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A live webcast in Norwegian will be held today, 27 February 2025, at 08:30am – 09:00am CET (local time).

The presentation can be followed as a live webcast, accessed through the link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20250227_1 or the company’s website under “Investors – Reports and presentations – Webcasts”.

There will be a Q&A session at the end of the presentation and it will be possible to post written questions through the webcast console.

The interim report and the presentation will also be available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com from 07:00am (CET) today.

For further information, please contact:
Ronny Skuggedal, CEO / CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

About PCI Biotech        
PCI Biotech is a biopharmaceutical company focusing on developing and commercialising new technologies and novel therapies through its photochemical technology platform originating from world-leading research at the Oslo University Hospital. The technology platform is under development in two different areas.        (1) Photochemical lysis (PCL), inducing selective light-triggered cell lysis, which may enhance yield and purity in viral vector manufacturing. (2) Photochemical internalisation (PCI), inducing light-triggered endosomal release, which may unlock the potential of a wide array of modalities.  

For further information, please visit: www.pcibiotech.com                 
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo

Forward-looking statements        
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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